In order to minimize the threat of infection to a patient during a surgical procedure, it is necessary that only sterile medical devices be used. Furthermore, strict adherence to sterile procedures is required to prevent the devices from becoming contaminated prior to use, especially during and after removal of the medical devices from sterile packages. In order to remove a sterile medical device from a sterile package, it is typically necessary for the medical professional to grasp the package with one hand while grasping and removing the device with the other hand. One type of sterile medical device which is frequently used is a surgical needle and suture combination. It is typical for most manufacturers to mount one or more needle and suture combinations in a primary suture package. Various surgical procedures require that multiple sutures be mounted in single primary package. As mentioned previously, surgical needles and sutures are mounted in a primary package which is then inserted into an outer package. The outer package is sealed and the entire combination is sterilized using conventional sterilization processes resulting in the needles, sutures, primary package and interior of the outer package being sterile. During a typical surgical procedure a circulating nurse opens the outer package while a scrub nurse removes the sterile inner primary package to complete the sterile transfer or a circulating nurse removes the sterile inner, primary package by opening the outer package and flipping it from the outer package onto a sterile tray in a sterile field without touching the sterile primary package.
During most surgical procedures, the surgeon requires the use of both hands when suturing. For example, one hand will be used to hold a needle grasper while the other hand will be used to manipulate tissue, organs, the incision, blood vessels, etc. Needles are grasped and removed from a primary surgical needle and suture package using the needle grasper. A needle grasper typically has plier-like jaws for holding a needle. The surgeon manipulates the needle grasper to push and pull the needle through tissue.
In order to eliminate the need for a surgeon or an assistant to hold a primary needle package while withdrawing needles and sutures, manufacturers have mounted strips of conventional double-sided tape to the exterior of primary needle and suture packages. The top side of the tape is typically mounted to the bottom exterior surface of the package. By pealing off a conventional release liner mounted to the bottom side of the tape to expose a bottom adhesive coating, the primary suture package may then be mounted to a surgical drape or other surface by pressing the package and exposed bottom adhesive coating against the surgical drape or surface. The surgeon may then pull needles and sutures from the primary package with one hand while having the other hand free.
Although the use of double sided tape has proven to be effective in mounting medical device packages such as primary surgical needle and suture packages to drapes and other surfaces, there are also disadvantages attendant with its use. Specifically, it is known that most conventional adhesives used to coat the surfaces of double-sided tape tend to flow when exposed to the environment of a typical sterilization process. This can cause the adhesive to migrate off of the tape surface beyond the periphery of a release liner and onto the outer surface of the primary package in which the sterile medical device is housed.
If the adhesive flows in such a manner beyond the periphery of a release liner and contacts the interior of the outer package, it may be difficult for a scrub nurse, circulating nurse, or other medical professional to remove the primary package from the outer package in the sterile field without compromising the sterility of the package. The adhesive may cause the primary package to stick to the outer package. Consequently, the circulating nurse would not be able to flip the package into the sterile field. If the primary package released at an inappropriate time during flipping because of sticking, the primary package could be misdirected out of the sterile field. Another concern would be if the primary package released and slid over the edge of the outer package and then landed in the sterile field. This situation would result in the contamination of the sterile field. The edge of the outer package is nonsterile. In addition, it may be necessary to grasp the outer surface of the outer package in order to remove the primary package, and, the outer surface of the outer package is not sterile. Therefore, grasping the primary package after having grasped the exterior of the outer package could result in the compromise of the sterility of the primary package and its contents.
Accordingly, there is a need in this art for improved sterile medical device packages having double-sided tape mounted to their exteriors for use in mounting the packages to surgical drapes or various other surfaces in the operating room.